Efficacy and Safety of Reslizumab in Patients with Severe Asthma with Inadequate Response to Omalizumab: A Multicenter, Open-Label Pilot Study

doi:10.1016/j.jaip.2019.01.017

The Journal of Allergy and Clinical Immunology: In Practice

Volume 7, Issue 7, September–October 2019, Pages 2277-2283.e2

https://doi.org/10.1016/j.jaip.2019.01.017 Get rights and content

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Background

Patients with severe allergic and eosinophilic asthma could qualify for different biologic therapies.

Objective

To evaluate the efficacy and safety of weight-based intravenous reslizumab dosing in patients who have previously failed therapy with omalizumab.

Methods

We carried out a 24-week prospective, multicenter, open-label, single-group, self-controlled study in patients with severe eosinophilic asthma who had previously failed to respond to omalizumab. The main objective was to determine whether treatment with reslizumab significantly improved asthma symptoms assessed by the Asthma Control Test (ACT) at week 24. Secondary objectives were to evaluate symptoms at weeks 4 and 12, change in FEV₁ at week 24, and the incidence of severe exacerbations over the study period.

Results

Twenty-nine patients (62.1% women, median age, 50.8 years) were included in the study. The median ACT score significantly increased from 13.0 (interquartile range, 8.0-18.0) at baseline to 21.0 (interquartile range, 14.0-24.0) at 24 weeks (P = .002). Only 2 of 29 patients developed at least 1 severe exacerbation during follow-up and none of them required hospitalization. Overall, 15 of 25 patients (60%) were considered as being controlled (ACT score of ≥20 and no exacerbations) at week 24. The percentage of patients who were receiving daily systemic corticosteroids significantly decreased from 72.4% to 52.0% (P = .019). Adverse events were mostly moderate and within the range of previously reported side effects with reslizumab.

Conclusion

Reslizumab is an effective and safe option for patients with severe eosinophilic asthma and a history of omalizumab failure.

Key words

Asthma

Asthma management

Severe asthma

Omalizumab

Reslizumab

Abbreviations used

ACQ

Asthma Control Questionnaire

ACT

Asthma Control Test

ATS

American Thoracic Society

ERS

European Respiratory Society

Feno

fraction of exhaled nitric oxide

ICS

inhaled corticosteroid

IQR

interquartile range

Cited by (0)

: This study was endorsed by the Asthma Research Program of the Spanish Respiratory Society (PII de Asma de SEPAR) supported by a grant from Teva Pharmaceutical Industries.

: Conflicts of interest: L. A. Perez de Llano reports personal fees from Novartis, AstraZeneca, GlaxoSmithKline, Teva, Boehringer-Ingelheim, Chiesi, Sanofi, Mundipharma, and Esteve; nonfinancial support from Novartis, GlaxoSmithKline, Teva, Boehringer-Ingelheim, Menarini, Mundipharma, and Esteve; and grants from AstraZeneca, Teva, and Chiesi, outside the submitted work. B. García-Cosío reports personal fees from Novartis, AstraZeneca, Teva, Boehringer-Ingelheim, Chiesi, Sanofi, and Mundipharma; nonfinancial support from Novartis, Teva, Boehringer-Ingelheim, and Menarini; and grants from AstraZeneca, GlaxoSmithKline, Teva, Boehringer-Ingelheim, and Chiesi, outside the submitted work. C. Domingo declares having received financial support for travel, speaker bureaus, or grants from Novartis, Sanofi, GlaxoSmithKline, Teva, Boehringer-Ingelheim, Esteve, Almirall, AstraZeneca, Chiesi, Menarini, Takeda, Pfizer, Ferrer, Stallergenes, Alk-Abelló, Allergy Therapeutics, Hall Allergy, and Inmunotek. I. Urrutia reports personal fees from AstraZeneca, Chiesi, GlaxoSmithKline, Menarini, Mundipharma, Novartis, and Teva; and nonfinancial support from Chiesi, GlaxoSmithKline, Mundipharma, Novartis, and Teva, outside the submitted work. I. Bobolea reports receiving fees as speaker or consultant for Novartis, GlaxoSmithKline, AstraZeneca, Teva, Chiesi, and Mundipharma, not related to the submitted work. A. Valero reports personal fees from AstraZeneca, Boehringer-Ingelheim, Chiesi, GlaxoSmithKline, Mundipharma, Novartis, and Sanofi, outside the submitted work. L. M. Entrenas Costa reports personal fees from AstraZeneca, Boehringer-Ingelheim, Chiesi, Esteve, Ferrer, GlaxoSmithKline, Menarini, Mundipharma, Novartis, Pfizer, and Teva; nonfinancial support from Chiesi, GlaxoSmithKline, Mundipharma, Novartis, and Teva; and grants from Novartis, Roche, Sanofi, and Teva, outside the submitted work. S. Quirce reports personal fees from Novartis, AstraZeneca, GlaxoSmithKline, Teva, Boehringer-Ingelheim, Chiesi, Sanofi, and Mundipharma; nonfinancial support from Novartis, AstraZeneca, GlaxoSmithKline, Teva, Sanofi, Boehringer-Ingelheim, Chiesi, and Mundipharma; and grants from Sanofi, outside the submitted work. P. Barranco reports personal fees from GlaxoSmithKline, AstraZeneca, Chiesi, Teva, and Novartis, outside the submitted work. N. M. Malanda reports fees as speaker for Novartis, GlaxoSmithKline, Teva, Chiesi, and Menarini, not related to the submitted work. L. P. Andrés reports no relevant conflicts of interest. F. J. Alvarez-Gutiérrez has received travel support, speaker fees, or grants from ALK-Abelló, AstraZeneca, Bial, Boheringer-Ingelheim, Chiesi, Esteve, GlaxoSmithKline, Menarini, Mundipharma, Novartis, and Teva.